Pennsylvania Code & Bulletin
COMMONWEALTH OF PENNSYLVANIA

• No statutes or acts will be found at this website.

The Pennsylvania Bulletin website includes the following: Rulemakings by State agencies; Proposed Rulemakings by State agencies; State agency notices; the Governor’s Proclamations and Executive Orders; Actions by the General Assembly; and Statewide and local court rules.

PA Bulletin, Doc. No. 09-14

NOTICES

DEPARTMENT OF HEALTH

Approved Prearrest and Evidential Breath Testing Devices

[39 Pa.B. 64]
[Saturday, January 3, 2009]

   The Department of Health (Department) has statutory authority to approve both prearrest and evidential breath testing devices for use by law enforcement officials to determine the alcohol content of blood by analysis of a person's breath. This notice differs from previous notices since it is a compilation of the lists of prearrest breath testing devices and evidential breath testing devices, which were previously published in separate notices.

   The Department approves prearrest breath testing devices as required by 28 Pa. Code §§ 5.101--5.104 (relating to equipment to determine blood alcohol content under the Vehicle Code and the Fish and Boat Code). Authority to promulgate those regulations is contained in the Vehicle Code, 75 Pa.C.S. § 1547(k) (relating to chemical testing to determine amount of alcohol or controlled substance), the Fish and Boat Code, 30 Pa.C.S. § 5125(k) (relating to chemical testing to determine amount of alcohol or controlled substance), the Game and Wildlife Code, 34 Pa.C.S. § 2502(j) (relating to chemical test to determine amount of alcohol), and section 2102(g) of The Administrative Code of 1929 (71 P. S. §  532(g)).

   Prearrest breath testing devices approved under this authority may be used by police officers, waterways patrolmen and officers enforcing the Vehicle Code, the Fish and Boat Code and the Game and Wildlife Code in conducting preliminary determinations of alcohol content of blood of persons suspected of driving, boating, hunting, or furtaking, while under the influence of alcohol. Officers and patrolmen use these devices to assist them in determining whether or not a person should be placed under arrest for violation of 75 Pa.C.S. § 3802 (relating to driving under influence of alcohol or controlled substance), for violation of 30 Pa.C.S. § 5502 (relating to operating watercraft under influence of alcohol or controlled substance), for violation of 34 Pa.C.S. § 2501 (relating to hunting or furtaking prohibited while under influence of alcohol or controlled substance), or for any other criminal offense under the Vehicle Code, the Fish and Boat Code, or the Game and Wildlife Code, which involves operating a vehicle or boat, hunting, or furtaking while under the influence of alcohol. This notice lists devices that were included in the previous publication of the list of approved prearrest breath testing devices, which appeared at 38 Pa.B. 321 (January 12, 2008).

   The National Highway Traffic Safety Administration (NHTSA) of the United States Department of Transportation published model specifications for Screening Devices to Measure Alcohol in Bodily Fluids in 59 FR 39382 (August 2, 1994). These specifications established performance criteria and methods for testing alcohol screening devices using either breath or bodily fluids such as saliva to measure blood alcohol content. NHTSA established these specifications to support state laws and the Federal Department of Transportation's workplace alcohol testing program. The Department has elected to use the NHTSA criteria for approving devices for the pre-arrest testing of a person's breath to determine the alcohol content of the person's blood.

   NHTSA published a conforming products list of alcohol screening devices in 72 FR 4559 (January 31, 2007). The breath testing devices included in this Federal approval list have been incorporated into the list in this notice. Since this notice lists only those devices which test breath, items on the NHTSA list that test saliva or other bodily fluids are not included in this notice.

   Additionally, there are a number of breath testing devices on this list of approved equipment that may be used as both prearrest and evidential testing devices. Any device on this list that was evaluated using the 1993 Model Specifications for Evidential Breath Testers (58 FR 48705) also fully meets the requirements of the Model Specifications for prearrest screening devices. Both procedures evaluate the performance of instruments at the 0.020% alcohol level.

   The Department approves evidential breath testing devices under the authority of 75 Pa.C.S. § 1547(c)(1), 30 Pa.C.S. § 5125(c)(1) and 34 Pa.C.S. § 2502(c).

   Evidential breath testing devices approved under this notice may be used by law enforcement officials to obtain test results which will be admissible in evidence in any summary or criminal proceeding in which the defendant is charged with a violation of 75 Pa.C.S. § 3802, or any other violation of the Vehicle Code arising out of the same action, or 30 Pa.C.S. § 5502, or any other violation of the Fish and Boat Code arising out of the same action, or 34 Pa.C.S. § 2501, or any other violation of the Game and Wildlife Code arising out of the same action. Law enforcement agencies should determine that an approved training program in the use of the equipment is available in accordance with the above referenced statutes before purchasing any of the devices contained on this list. This notice lists evidentiary breath testing devices that were included in the previous publication of the list of evidential breath testing devices, which appeared at 38 Pa.B. 944 (February 16, 2008).

   The approval of evidential equipment listed in this notice is based on the evaluation of the equipment by NHTSA. Equipment which met the Federal requirements was published at 72 FR 71480 (December 17, 2007) as a Conforming Products List. The list contained in this notice is based on that Conforming Products List.

   Instruments marked with an asterisk (*) meet the Model Specifications detailed in 49 FR 48854 (December 14, 1984) (that is, instruments tested at breath alcohol concentrations of 0.000, 0.050, 0.101, and 0.151 grams of alcohol per 210 liters of air). Instruments not marked with an asterisk meet the Model Specifications detailed in 58 FR 48705 (September 17, 1993), and were tested at breath alcohol concentrations of 0.000, 0.020, 0.040, 0.080, and 0.160 grams of alcohol per 210 liters of air. The amended specifications that were published on September 17, 1993, added a test for the presence of other low molecular weight alcohols including methyl and isopropyl. Instruments whose precision and accuracy have been evaluated in the latter concentration range (that is, devices not marked with an asterisk) should be used when reliable results are required at blood alcohol concentrations below 0.050%.

   NHTSA also evaluates equipment to determine if it must be operated at fixed locations (that is, nonmobile equipment) or can be transported to nonfixed operational sites in the field (mobile equipment). Most equipment on the list is approved for mobile and nonmobile operation. The listing at the end of this notice specifies nonmobile equipment only.

   The instruments not marked with an asterisk meet the specifications for use as prearrest or evidentiary breath testing devices. The instruments marked with an asterisk may be used as evidentiary devices for law enforcement purposes that are concerned with blood alcohol concentrations at or above 0.050%. These instruments may also be used as prearrest breath testing devices if they are approved for mobile operations. However, these instruments may not be effective for arrests under the Vehicle Code, the Fish and Boat Code, or the Game and Wildlife Code where blood alcohol concentrations below 0.050% are acceptable. Nonmobile devices can only be used as evidentiary testing instruments since they are not portable. Before purchasing breath testing devices, law enforcement officials should consult with the manufacturer of the equipment they intend to purchase to verify that the devices can be used for their intended purposes.

   Law enforcement agencies that plan to utilize a device which does not appear on the following list should contact the manufacturer of the equipment to verify that it has been evaluated by NHTSA and found to meet NHTSA's performance requirements. If a device is approved by NHTSA after the date of this publication, the manufacturer of the device will need to forward documentation of NHTSA acceptability to Dr. M. Jeffery Shoemaker at the address given below so that the Department has information sufficient to enable it to include the device in the next revision of this notice in the Pennsylvania Bulletin.

   Some of the devices included in this notice are listed under the name of more than one manufacturer. This is due to the fact that the name of the manufacturer has changed or the right to produce a device has been transferred to a different company. In such instances, the device is listed under the name of every company that was ever associated with the device in order to allow law enforcement agencies to continue using devices bearing the name of a previous manufacturer.

   To facilitate accessibility to information concerning breath alcohol testing devices which are approved for law enforcement purposes in the Commonwealth, the Department will publish revisions of this list of equipment semiannually as notices in the Pennsylvania Bulletin. This practice is being implemented in 2009 and will proceed even if an updated conforming products list has not appeared in the Federal Register since the Department's last annual publication of approved breath testing devices.

   Questions regarding this list should be directed to Dr. M. Jeffery Shoemaker, Director, Division of Chemistry and Toxicology, Department of Health, Bureau of Laboratories, P. O. Box 500, Exton, PA 19341-0500, (610) 280-3464.

   Persons with a disability who require an alternative format of this notice (for example, large print, audiotape, Braille) should contact Dr. Shoemaker at V/TT (717) 783-6514 or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT).

AK Solutions, Inc., Palisades Park, NJ1
   Alcoscan AL-2500
AlcoChecker
AlcoKey
AlcoMate
AlcoMate Pro
Alcoscan AL-5000
Alcoscan AL-6000

Akers Laboratories, Inc., Thorofare, NJ
   Alcohol RADICALTM

Akers Biosciences, Inc., Thorofare, NJ
   Breath Alcohol RADICAL .02 Detection System2

Alco Check International, Hudsonville, MI
   Alco Check 3000 D.O.T.
Alco Check 9000
Alco Screen 3000

Alcohol Countermeasures Systems, Inc., Port    Hurton, MI
   Alert J3AD*
PBA 3000C

Alcohol Countermeasure Systems Corp., Missis   sauga, Ontario, Canada
   Alert J3AD*
   Alert J4X.ec
   PBA3000C

Alcohol Countermeasure Systems, Inc., Cincinnati,    OH
   Alert J4

Approved Technology, Inc., Grand Rapids, MI
   Alco-Check I
   Alco-Check II
   Alco-Check 3000

BAC Systems, Inc., Ontario, Canada
   Breath Analysis Computer*

BHP Diagnostix, West Chester, PA
   Prevent

CAMEC Ltd., North Shields, Tyne and Ware, Eng   land
   IR Breath Analyzer*

CMI-MPH, Owensboro, KY
   CMI S-D2
   CMI S-L2

CMI, Inc., Owensboro, KY
   Intoxilyzer Model:
      200
200D
240 (aka Lion Alcolmeter 400 + outside the US)
300
400
400PA
1400
4011*
4011A*
4011AS*
4011AS-A*
4011AS-AQ*
4011AW*
4011A27-10100*
4011A27-10100 with filter*
5000
5000 (w/Cal. Vapor Re-Circ.)
5000 (w/3/8" ID hose option)
5000CD
5000CD/FG5
5000EN
5000 (CAL DOJ)
5000 (VA)
8000
PAC 1200*
S-D2
S-D5

Craig Technologies International Ltd., Aurora, CO
   BreathScan

Decator Electronics, Decator, IL
   
Alco-Tector model 500*

Draeger Safety, Inc., (aka: National Draeger)    Durango, CO
   Alcotest Model:
      6510
6810
7010*
7110*
7110 MKIII
7110 MKIII-C
7410
7410 Plus
9510
   Breathalyzer Model:
      900*
900A*
900BG*
7410
7410-II

EnviteC by Honeywell GmbH. Fond du Lac, WI
   AlcoQuant 6020

Gall's Inc., Lexington, KY
   Alcohol Detection System--A.D.S. 500

Guth Laboratories, Inc., Harrisburg, PA
   Alco-Tector
Alco-Tector Mark X
Alcotector BAC-100
Alcotector C2H5OH
Alcotector WAT90
Mark X Alcohol Checker
Alcotector WAT89EC-1

Han International Co., Ltd., Seoul, Korea
   A.B.I. (Alcohol Breath Indicator)3

Intoximeters, Inc., St. Louis, MO
   Indium Encapsulation System
Photo Electric Intoximeter*
GC Intoximeter MK II*
GC Intoximeter MK IV*
Auto Intoximeter*
Intox EC-IR
Intox EC-IR 2
Portable Intox EC-IR

Intoximeter Model:
   3000*
3000 (rev B1)*
3000 (rev B2)*
3000 (rev B2A)*
3000 (rev B2A) w/FM option*
3000 (Fuel Cell)*
3000D*
3000DFC*
Alcomonitor
Alcomonitor CC
Alco-Sensor
Alco-Sensor III
Alco-Sensor III (Enhanced with Serial Numbers above    1,200,000)
Alco-Sensor IV
Alco-Sensor IV-XL
Alco-Sensor AZ
Alco-Sensor FST
Alco-Sensor Light Display
EC/IR
EC/IR II
EC/IR II (enhanced with serial number 10,000 or    higher)
Portable EC/IR II
RBT-AZ
RBT III
RBT III-A
RBT-IV
RBT-IV with CEM (cell enhancement module)

Komyo Kitagawa, Kogyo, K.K.:
   Alcolyzer DPA-2*
   Breath Alcohol Meter PAM 101B*

Lifeloc Technologies, Inc. (formerly Lifeloc, Inc.)    Wheat Ridge, CO:
   Life Loc PBA 3000
PBA 3000-B
PBA 3000-P*
PBA 3000-C
Alcohol Data Sensor
Phoenix
Phoenix 6.0
EV 30
FC 10
FC 20

Lion Laboratories, Ltd., Cardiff, Wales, UK
   Alcolmeter Model:
      
Auto-Alcolmeter*
300
400
400+ (aka: Intoxilzyer 240 in the U.S.)
SD-2*
SD-5 (aka: S-D5 in the U.S.
EBA*
   Intoxilyzer Model:
      200
200D
1400
5000 CD/FG5
5000 EN

Luckey Laboratories, San Bernardino, CA
   Alco-Analyzer Model:
      
Mobat Sober-Meter-SM II
1000*
2000*

Medi-Scan, Inc., Denver, CO
   BreathScan

National Draeger, Inc., Durango, CO
   Alcotest Model:
      
7010*
7110*
7110 MKIII
7110 MKIII-C
7410
7410 Plus
7410 Screener
9510
6510
6810
   Breathalyzer Model:
      900*
900A*
900BG*
7410
7410-II

National Draeger, Inc., Pittsburgh, PA
   
Alcotest

National Patent Analytical Systems, Inc., Mansfield,    OH
   BAC DataMaster (with or without the Delta-1 acces   sory)
BAC Verifier DataMaster (with or without the Delta-1    accessory
DataMaster cdm (with or without the Delta-1 acces   sory)
DataMaster DMT

Omicron Systems, Palo Alto, CA
   Intoxilyzer 4011*
   Intoxilyzer 4011AW*

PAS Systems International, Inc., Fredericksburg,    VA
   PAS IIIa
   PAS Vr

Plus 4 Engineering, Minturn, CO
   5000 Plus 4*

Q3 Innovations, Inc., Independence, IA4
   AlcoHAWK Precision
AlcoHAWK Slim
AlcoHAWK Elite
AlcoHAWK ABI
AlcoHAWK Micro
AlcoHAWK PRO

RepCo Marketing, Raleigh, NC
   Alco Tec III
AlcoTec Breath-Alcohol Tester
Breath Alcohol Tester Model BT-2
Breath Alcohol Tester Model BT-3

Seju Co. of Taejeon, Korea
   Safe-Slim

Seres, Paris, France
   Alco Master
   Alcopro

Siemans-Allis, Cherry Hill, NJ
   Alcomat*
   Alcomat F*

Smith and Wesson Electronics, Springfield, MA
   Breathalyzer Model:
      900*
900A*
1000*
2000*
2000 (Non-Humidity Sensor)*

SoundOff, Inc., Hudsonville, MI
   Alco-Check
Alco-Check II
AlcoData
Alco Screen 1000
Digitox D.O.T.
Preliminary Breath Test II
Seres Alco Master
Seres Alcopro

Stephenson Corp.
   Breathalyzer 900*

Takai-Denshi Inc., Tokyo, Japan:
   ALC-PRO II (US)

Team Building Systems, Inc., Houston, TX
   BreathScan

U.S. Alcohol Testing, Inc./Protection Devices, Inc.,    Rancho Cucamonga, CA
   Alco-Analyzer 1000
   Alco-Analyzer 2000
   Alco-Analyzer 2100

Verax Systems, Inc., Fairport, NY
   BAC Verifier*
   BAC Verifier Datamaster
   BAC Verifier Datamaster II*

Nonmobile only

Decator Electronics
   Alco-Tector model 500*

Draeger Safety, Inc.
   Alcotest Model 9510

Intoximeters, Inc.
   Photo Electric Intoximeter*
   Intoximeter Model--Alcomonitor
   Intoximeter Model--EC/IR II (enhanced with serial       number 10,000 or higher)

Lion Laboratories, Ltd.
   Auto-Alcolmeter*

Luckey Laboratories
   Alco-Analyzer Model--1000*
   Alco-Analyzer Model--2000*

U.S. Alcohol Testing, Inc./Protection Devices, Inc.,    Rancho Cucamonga, CA
   Alco-Analyzer 1000
   Alco-Analyzer 2000

A. EVERETTE JAMES,   
Acting Secretary

[Pa.B. Doc. No. 09-14. Filed for public inspection January 2, 2009, 9:00 a.m.]

_______

1 The AlcoMate was manufactured by Han International of Seoul, Korea, but marketed and sold in the US by AK Solutions.

2  The Breath Alcohol RADICAL.02 Detection System consists of a single-use disposable breath tube used in conjunction with an electronic analyzer that determines the test result. The electronic analyzer and the disposable breath tubes are lot specific and manufactured to remain calibrated throughout the shelf-life of the device. This screening device cannot be used after the expiration date.

3  Han International does not market or sell devices directly in the US market. Other devices manufactured by Han International are listed under AK Solutions, Inc. and Q-3 Innovations, Inc.

4  The AlcoHAWK ABI is the same device as that listed under Han International as the ''ABI'' and is manufactured for Q-3 Innovations by Han International. The AlcoHAWK PRO is the same device as the AlcoMate marketed and sold by AK Solutions, and also manufactured by Han International.



No part of the information on this site may be reproduced for profit or sold for profit.

This material has been drawn directly from the official Pennsylvania Bulletin full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.